[go: up one dir, main page]

WO2006085327A1 - Medical device for in situ liquid drug reconstitution in medicinal vessels - Google Patents

Medical device for in situ liquid drug reconstitution in medicinal vessels Download PDF

Info

Publication number
WO2006085327A1
WO2006085327A1 PCT/IL2006/000181 IL2006000181W WO2006085327A1 WO 2006085327 A1 WO2006085327 A1 WO 2006085327A1 IL 2006000181 W IL2006000181 W IL 2006000181W WO 2006085327 A1 WO2006085327 A1 WO 2006085327A1
Authority
WO
WIPO (PCT)
Prior art keywords
vessel
diluent
medicinal
liquid drug
flow
Prior art date
Application number
PCT/IL2006/000181
Other languages
French (fr)
Inventor
Freddy Zinger
Igor Denenburg
Original Assignee
Medimop Medical Projects Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medimop Medical Projects Ltd filed Critical Medimop Medical Projects Ltd
Priority to EP20060711163 priority Critical patent/EP1848393B1/en
Priority to DE200660017334 priority patent/DE602006017334D1/en
Priority to US11/816,185 priority patent/US7862537B2/en
Priority to AT06711163T priority patent/ATE483442T1/en
Publication of WO2006085327A1 publication Critical patent/WO2006085327A1/en
Priority to IL184960A priority patent/IL184960A/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2037—Separating means having valve means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2058—Connecting means having multiple connecting ports

Definitions

  • the invention is in the field of medical devices for in situ liquid drug reconstitution in medicinal vessels.
  • Certain liquid drugs are preferably stored in powder form for subsequent reconstitution by a diluent which may or may not contain an active medicinal ingredient prior to administration to a patient.
  • a diluent which may or may not contain an active medicinal ingredient prior to administration to a patient.
  • Single dosage vials sealed by a rubber stopper are commonly employed for storing liquid drugs in powder form. Reconstitution of the powder drug contents of such single dosage vials involves puncturing their rubber stoppers and injecting a predetermined volume of diluent.
  • Suitable medical devices for in situ liquid drug reconstitution in single dosage vials include inter alia metal needles, plastic spikes, and a range of medical devices commercially available from Medimop Medical Projects Ltd, Ra'anana, Israel (www.medimop.com) including vial adapters, MIXJECT ® fluid control devices illustrated and described in Applicant's PCT International Publication No. WO 96/29113, in-line MIXJECT ® fluid control devices illustrated and described in Applicant's PCT International Publication No. WO 2005/105014 (see Figures 1-7), and the like.
  • 5,454,786 to Harris illustrates and describes a medical device for directing an injected flow of diluent against a vial's surface above its powder contents to avoid foaming.
  • US Patent No. 6,719,719 to Carmel et al. illustrates and describes a spike for directing an injected flow of diluent also above a vial's powder drug contents to avoid foaming (see Figure 5).
  • a sharp initial injection force to overcome static friction at a syringe's gasket may inject diluent into a vial at such a rate to still cause foaming of its powder drug contents even if the injected flow of diluent does not directly impinge thereon.
  • a high powered stream of diluent undesirably increases the dissolving time of powder drug contents in comparison to a slow stream of diluent.
  • the present invention is directed toward medical devices for in situ liquid drug reconstitution in medicinal vessels containing drug contents including a one-way flow restriction mechanism for positively restricting injection of diluent into a medicinal vessel but only slightly restricting aspiration of reconstituted liquid drug therefrom, if at all.
  • One-way flow restriction mechanisms preferably include a pin-like flow restrictor reciprocal between a flow restricting position on injecting diluent into a medicinal vessel and a non-flow restricting position on aspirating reconstituted liquid drug therefrom.
  • Flow restrictors can be formed from a wide range of suitable metal and plastic bio-compatible materials, and weigh very little due to their small size.
  • injection of diluent into a medicinal vessel or aspiration of reconstituted liquid drug therefrom determines the reciprocation of a flow restrictor between its extreme positions irrespective of the attitude of a medical device.
  • the present invention can be readily applied to the aforesaid medical devices employed for in situ liquid drug reconstitution, and is particularly advantageous for use with single dosage medicinal vessels due to the afore-mentioned problem of precise volumes of liquid drugs but it can be equally used with multiple dosage medicinal vessels.
  • the present invention is particularly advantageous for use with medicinal vessels containing powder drug contents but is also advantageous for use with medicinal vessels containing liquid drug contents requiring reconstitution.
  • Fig. 1 is a longitudinal cross section of a medical device including a first preferred embodiment of a one-way flow restriction mechanism prior to in situ liquid drug reconstitution in a single dosage vial containing powder drug contents;
  • Fig. 2 is an enlarged view of a central region of the medical device denoted A in Figure 1 showing its one-way flow restriction mechanism in its flow restricting state;
  • Fig. 3 is a perspective view of a first preferred embodiment of a flow restrictor of a one-way flow restriction mechanism
  • Fig. 4 is a longitudinal cross section of Figure l's medical device subsequent to liquid drug reconstitution in the single dosage vial and prior to aspiration of the reconstituted liquid drug therefrom for administration to a patient;
  • Fig. 5 is an enlarged view of the central region of Figure 4's medical device showing its one-way flow restriction mechanism in its non-flow restricting state; and Fig. 6 is a longitudinal cross section of a medical device including a second preferred embodiment of a one-way flow restriction mechanism in accordance with the present invention with a second preferred embodiment of a flow restrictor.
  • Figure 1 shows a medical device 10 similar in construction and operation to a MIXJECT ® fluid control device illustrated and described in Applicant's PCT International Publication No. WO 96/29113 and commercially available from Medimop Medical Projects Ltd, Ra'anana, Israel.
  • the medical device 10 differs from a conventional MIXJECT ® fluid control device insofar that it includes a one-way flow restriction mechanism 11 for positively restricting injection of diluent from a pre-filled syringe S into a single dosage vial V containing powder drug contents for in situ liquid drug reconstitution therein and only slightly restricting aspiration of the reconstituted liquid drug therefrom relative to a conventional MIXJECT ® fluid control device, if at all.
  • the one-way flow restriction mechanism 11 includes a pin-like flow restrictor 12 and a stopper 13 for enabling reciprocation of the flow restrictor 12 between a flow restricting position (see Figure 2) and a non-flow restricting position (see Figure 5).
  • the medical device 10 includes an elongated housing 16 having a syringe port 17 for receiving the pre-filled syringe S, and a needle port 18 fitted with a needle 19 protected by a needle protector 21.
  • the housing 16 includes a transversely directed lumen 22 with a flow control member 23 rotatably mounted therein, and having a port 24 (see Figure 2).
  • the medical device 10 includes a vial adapter 26 screw threadingly attached to the housing 16 and having an elongated tubular puncturing member 27 with a pointed end 28 and a flow control member end 29.
  • the pointed end 28 punctures an initially sealed vial V on snap fit insertion into the vial adapter 26.
  • the flow control member end 29 extends into the port 24 for rotating the flow control member 23 from a first operative position for enabling a first flow path between the syringe S and the interior of a punctured vial V as shown in Figure 1 to a second operative position for enabling a second flow path between the syringe S and the needle 19 whereupon the vial adapter 26 can be detached from the housing 16 together with the spent vial V.
  • the flow control member end 29 is inwardly crimpled to form an annular support surface 29A for enabling reciprocation of the flow restrictor 12.
  • Figure 3 shows the flow restrictor 12 has a wide diameter head 31 with a topside 32, an underside 33, and a peripheral surface 34, and a downward depending shank 36 formed with a longitudinally directed cutaway 37 and terminating in a pair of diametrically opposite directed wings 38 with topsides 39 facing the head's underside 33.
  • the head's underside 33 is formed with a radial groove 41 extending inwards from the head's peripheral surface 34 and in flow communication with the longitudinally directed cutaway 37.
  • the groove 41 preferably faces away from the syringe port 17 for further ensuring that even a sharp injection force only results in a slow introduction of diluent into a vial V via the groove 41 and the cutaway 37 to reduce frothing of its powder drug contents.
  • the head 31 has a diameter Dl
  • the shank 36 has a diameter D2
  • the wings 38 define a diameter D3
  • the support surface 29A defines an internal diameter D4 where D1>D4, D3>D4 and
  • the use of the medical device 10 for in situ liquid drag reconstitution suitable for administration to a patient is as follows: A user holds the medical device 10 with the vial V facing downwards ready for injection of diluent thereinto (see Figure 1). The user injects diluent into the vial V thereby urging the flow restrictor 12 into its flow restricting position with its head's underside 33 stopped against the support surface 29A (see Figure 2). In this position, the flow restrictor 12 restricts the injected flow rate of the diluent to reduce foaming, and the dissolving time of the powder drag contents. The user gently agitates the vial V to reconstitute the powder drug contents.
  • the user inverts the medical device 10 ready for aspiration of the reconstituted liquid drug into the syringe S (see Figure 4).
  • the user aspirates the reconstituted liquid drag displacing the flow restrictor 12 into its non-flow restricting position with its wings' topsides 39 stopped against the support surface 29A (see Figure 5).
  • the user rotates the vial adapter 26 to remove the same together with the now spent vial V whereupon the medical device 10 is ready for administration of the reconstituted liquid drug to a patient.
  • Figure 6 shows a vial adapter 50 similar in construction and operation to a vial adapter illustrated and described in commonly owned US Patent No. Des. 427,308 and commercially available from Medimop Medical Projects Ltd, Ra'anana, Israel, and differing therefrom insofar that it includes a one-way flow restriction mechanism 51 for positively restricting injection of diluent from a syringe into a medicinal vessel containing powder drug contents for in situ liquid drug reconstitution therein and only slightly restricting aspiration of reconstituted liquid drug therefrom in comparison to a conventional vial adapter, if at all.
  • a one-way flow restriction mechanism 51 for positively restricting injection of diluent from a syringe into a medicinal vessel containing powder drug contents for in situ liquid drug reconstitution therein and only slightly restricting aspiration of reconstituted liquid drug therefrom in comparison to a conventional vial adapter, if at all.
  • the vial adapter 50 includes a female Luer connector 52 in flow communication with an elongated tubular puncturing member 53 having a stepped internal diameter including a wide diameter trailing section 54, a narrow diameter tapering leading section 56 relative to its pointed end 57, and an annular support surface 58 intermediate the trailing section 54 and the leading section 56.
  • the female Luer connector 52 houses a filter 59 which can be disc shaped, ring shaped, and the like.
  • the trailing section 54 houses a flow restrictor 61 which has the same construction as the flow restrictor 12 but without , its wings 38. In this embodiment, the flow restrictor 61 is positively urge,d against the support surface 58 on injection of diluent into a medicinal vessel and against the filter 59 on aspiration of reconstituted liquid drug therefrom. .

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Surgical Instruments (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

Medical device for in situ liquid drug reconstitution in medicinal vessels containing drug contents. The medical device includes a body member having a vessel port for insertion into a medicinal vessel containing drug contents, and a syringe port for receiving a syringe containing a diluent for reconstituting the drug contents into a reconstituted liquid drug. The medical device includes a one-way flow restriction mechanism between the two ports for positively restricting injection of diluent into a medicinal vessel but only slightly restricting aspiration of reconstituted liquid drug therefrom, if at all.

Description

MEDICAL DEVICE FOR IN SITU LIQUID DRUG RECONSTITUTION IN MEDICINAL VESSELS
Field of the Invention
The invention is in the field of medical devices for in situ liquid drug reconstitution in medicinal vessels.
Background of the Invention
Certain liquid drugs are preferably stored in powder form for subsequent reconstitution by a diluent which may or may not contain an active medicinal ingredient prior to administration to a patient. Single dosage vials sealed by a rubber stopper are commonly employed for storing liquid drugs in powder form. Reconstitution of the powder drug contents of such single dosage vials involves puncturing their rubber stoppers and injecting a predetermined volume of diluent. Suitable medical devices for in situ liquid drug reconstitution in single dosage vials include inter alia metal needles, plastic spikes, and a range of medical devices commercially available from Medimop Medical Projects Ltd, Ra'anana, Israel (www.medimop.com) including vial adapters, MIXJECT® fluid control devices illustrated and described in Applicant's PCT International Publication No. WO 96/29113, in-line MIXJECT® fluid control devices illustrated and described in Applicant's PCT International Publication No. WO 2005/105014 (see Figures 1-7), and the like.
Users often have to apply a sharp initial injection force to overcome static friction at a syringe's gasket which injects a high powered stream of diluent into a vial causing its powder drug contents to foam. Users typically reconstitute a liquid drug immediately prior to use but frothy reconstituted liquid drugs take several hours to fully settle such that users have to decide to either aspirate as much of a frothy reconstituted liquid drug as possible immediately after reconstitution or reconstitute another vial in , certain cases requiring precise volumes of a reconstituted liquid drug to be administered. US Patent No. 5,454,786 to Harris illustrates and describes a medical device for directing an injected flow of diluent against a vial's surface above its powder contents to avoid foaming. Similarly, US Patent No. 6,719,719 to Carmel et al. illustrates and describes a spike for directing an injected flow of diluent also above a vial's powder drug contents to avoid foaming (see Figure 5). However, in practice, it has been found that a sharp initial injection force to overcome static friction at a syringe's gasket may inject diluent into a vial at such a rate to still cause foaming of its powder drug contents even if the injected flow of diluent does not directly impinge thereon. Moreover, a high powered stream of diluent undesirably increases the dissolving time of powder drug contents in comparison to a slow stream of diluent.
Summary of the Invention , ;
The present invention is directed toward medical devices for in situ liquid drug reconstitution in medicinal vessels containing drug contents including a one-way flow restriction mechanism for positively restricting injection of diluent into a medicinal vessel but only slightly restricting aspiration of reconstituted liquid drug therefrom, if at all. One-way flow restriction mechanisms preferably include a pin-like flow restrictor reciprocal between a flow restricting position on injecting diluent into a medicinal vessel and a non-flow restricting position on aspirating reconstituted liquid drug therefrom. Flow restrictors can be formed from a wide range of suitable metal and plastic bio-compatible materials, and weigh very little due to their small size. Accordingly, injection of diluent into a medicinal vessel or aspiration of reconstituted liquid drug therefrom determines the reciprocation of a flow restrictor between its extreme positions irrespective of the attitude of a medical device. The present invention can be readily applied to the aforesaid medical devices employed for in situ liquid drug reconstitution, and is particularly advantageous for use with single dosage medicinal vessels due to the afore-mentioned problem of precise volumes of liquid drugs but it can be equally used with multiple dosage medicinal vessels. Moreover, the present invention is particularly advantageous for use with medicinal vessels containing powder drug contents but is also advantageous for use with medicinal vessels containing liquid drug contents requiring reconstitution.
Brief Description of the Drawings In order to understand the invention and to see how it can be carried out in practice, preferred embodiments will now be described, by way of non-limiting examples only, with reference to the accompanying drawings in which similar parts are likewise numbered, and in which:
Fig. 1 is a longitudinal cross section of a medical device including a first preferred embodiment of a one-way flow restriction mechanism prior to in situ liquid drug reconstitution in a single dosage vial containing powder drug contents;
Fig. 2 is an enlarged view of a central region of the medical device denoted A in Figure 1 showing its one-way flow restriction mechanism in its flow restricting state;
Fig. 3 is a perspective view of a first preferred embodiment of a flow restrictor of a one-way flow restriction mechanism;
Fig. 4 is a longitudinal cross section of Figure l's medical device subsequent to liquid drug reconstitution in the single dosage vial and prior to aspiration of the reconstituted liquid drug therefrom for administration to a patient;
Fig. 5 is an enlarged view of the central region of Figure 4's medical device showing its one-way flow restriction mechanism in its non-flow restricting state; and Fig. 6 is a longitudinal cross section of a medical device including a second preferred embodiment of a one-way flow restriction mechanism in accordance with the present invention with a second preferred embodiment of a flow restrictor. Detailed Description of the Drawings of the Preferred Embodiments
Figure 1 shows a medical device 10 similar in construction and operation to a MIXJECT® fluid control device illustrated and described in Applicant's PCT International Publication No. WO 96/29113 and commercially available from Medimop Medical Projects Ltd, Ra'anana, Israel. The medical device 10 differs from a conventional MIXJECT® fluid control device insofar that it includes a one-way flow restriction mechanism 11 for positively restricting injection of diluent from a pre-filled syringe S into a single dosage vial V containing powder drug contents for in situ liquid drug reconstitution therein and only slightly restricting aspiration of the reconstituted liquid drug therefrom relative to a conventional MIXJECT® fluid control device, if at all. The one-way flow restriction mechanism 11 includes a pin-like flow restrictor 12 and a stopper 13 for enabling reciprocation of the flow restrictor 12 between a flow restricting position (see Figure 2) and a non-flow restricting position (see Figure 5). The medical device 10 includes an elongated housing 16 having a syringe port 17 for receiving the pre-filled syringe S, and a needle port 18 fitted with a needle 19 protected by a needle protector 21. The housing 16 includes a transversely directed lumen 22 with a flow control member 23 rotatably mounted therein, and having a port 24 (see Figure 2). The medical device 10 includes a vial adapter 26 screw threadingly attached to the housing 16 and having an elongated tubular puncturing member 27 with a pointed end 28 and a flow control member end 29. The pointed end 28 punctures an initially sealed vial V on snap fit insertion into the vial adapter 26. The flow control member end 29 extends into the port 24 for rotating the flow control member 23 from a first operative position for enabling a first flow path between the syringe S and the interior of a punctured vial V as shown in Figure 1 to a second operative position for enabling a second flow path between the syringe S and the needle 19 whereupon the vial adapter 26 can be detached from the housing 16 together with the spent vial V. The flow control member end 29 is inwardly crimpled to form an annular support surface 29A for enabling reciprocation of the flow restrictor 12.
Figure 3 shows the flow restrictor 12 has a wide diameter head 31 with a topside 32, an underside 33, and a peripheral surface 34, and a downward depending shank 36 formed with a longitudinally directed cutaway 37 and terminating in a pair of diametrically opposite directed wings 38 with topsides 39 facing the head's underside 33. The head's underside 33 is formed with a radial groove 41 extending inwards from the head's peripheral surface 34 and in flow communication with the longitudinally directed cutaway 37. The groove 41 preferably faces away from the syringe port 17 for further ensuring that even a sharp injection force only results in a slow introduction of diluent into a vial V via the groove 41 and the cutaway 37 to reduce frothing of its powder drug contents. The head 31 has a diameter Dl, the shank 36 has a diameter D2, the wings 38 define a diameter D3, and the support surface 29A defines an internal diameter D4 where D1>D4, D3>D4 and D4>D2.
The use of the medical device 10 for in situ liquid drag reconstitution suitable for administration to a patient is as follows: A user holds the medical device 10 with the vial V facing downwards ready for injection of diluent thereinto (see Figure 1). The user injects diluent into the vial V thereby urging the flow restrictor 12 into its flow restricting position with its head's underside 33 stopped against the support surface 29A (see Figure 2). In this position, the flow restrictor 12 restricts the injected flow rate of the diluent to reduce foaming, and the dissolving time of the powder drag contents. The user gently agitates the vial V to reconstitute the powder drug contents. The user inverts the medical device 10 ready for aspiration of the reconstituted liquid drug into the syringe S (see Figure 4). The user aspirates the reconstituted liquid drag displacing the flow restrictor 12 into its non-flow restricting position with its wings' topsides 39 stopped against the support surface 29A (see Figure 5). Subsequent to aspiration, the user rotates the vial adapter 26 to remove the same together with the now spent vial V whereupon the medical device 10 is ready for administration of the reconstituted liquid drug to a patient.
Figure 6 shows a vial adapter 50 similar in construction and operation to a vial adapter illustrated and described in commonly owned US Patent No. Des. 427,308 and commercially available from Medimop Medical Projects Ltd, Ra'anana, Israel, and differing therefrom insofar that it includes a one-way flow restriction mechanism 51 for positively restricting injection of diluent from a syringe into a medicinal vessel containing powder drug contents for in situ liquid drug reconstitution therein and only slightly restricting aspiration of reconstituted liquid drug therefrom in comparison to a conventional vial adapter, if at all. The vial adapter 50 includes a female Luer connector 52 in flow communication with an elongated tubular puncturing member 53 having a stepped internal diameter including a wide diameter trailing section 54, a narrow diameter tapering leading section 56 relative to its pointed end 57, and an annular support surface 58 intermediate the trailing section 54 and the leading section 56. The female Luer connector 52 houses a filter 59 which can be disc shaped, ring shaped, and the like. The trailing section 54 houses a flow restrictor 61 which has the same construction as the flow restrictor 12 but without , its wings 38. In this embodiment, the flow restrictor 61 is positively urge,d against the support surface 58 on injection of diluent into a medicinal vessel and against the filter 59 on aspiration of reconstituted liquid drug therefrom. .
While the invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications, and other applications of the invention can be made within the scope of the appended claims.

Claims

Claims:
1. A medical device for use with a medicinal vessel containing drug contents and a syringe containing a diluent for reconstituting the drug contents to a reconstituted liquid drug, the device comprising:
(a) a body member having a syringe port for receiving the syringe, and a vessel port for insertion into the medicinal vessel and in flow communication with said syringe port; and
(b) a one-way flow restriction mechanism deployed intermediate said syringe port and said vessel port for positively restricting injection of diluent into the medicinal vessel for in situ liquid drug reconstitution therein and only slightly restricting aspiration of reconstituted liquid drug therefrom, if at all.
2. The device according to Claim 1 wherein said one-way flow restriction mechanism includes a flow restrictor reciprocal between a flow restricting position on injecting diluent into the medicinal vessel and a non-flow restricting position on aspirating reconstituted liquid drug therefrom.
3. The device according to Claim 2 wherein said flow restrictor has a pin shape with a wide diameter head and a downward depending shank, said head has an underside positively urged against a support surface on injection of diluent into the medicinal vessel, and said underside has a radial groove for positively restricting injection of diluent into the medicinal vessel.
4. The device according to Claim 3 wherein said support surface stops displacement of said flow restrictor at said flow restricting position on injecting diluent into the medicinal vessel and at said non-flow restricting position on aspirating reconstituted liquid drug from the medicinal vessel.
5. The device according to Claim 3 wherein said radial groove is directed away from said syringe port.
6. The device according to any one of Claims 1 to 5 wherein said vessel port is fashioned as a puncturing member for puncturing a stopper sealing a medicinal vessel.
7. The device according to any one of Claims 1 to 6 wherein said body member is fashioned as a vial adapter for snap fitting onto a medicinal vessel.
PCT/IL2006/000181 2005-02-14 2006-02-13 Medical device for in situ liquid drug reconstitution in medicinal vessels WO2006085327A1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
EP20060711163 EP1848393B1 (en) 2005-02-14 2006-02-13 Medical device for in situ liquid drug reconstitution in medicinal vessels
DE200660017334 DE602006017334D1 (en) 2005-02-14 2006-02-13 MEDICAL DEVICE FOR THE RECONSTITUTION OF A LIQUID MEDICAMENT IN SITU IN MEDICAL VACUUM
US11/816,185 US7862537B2 (en) 2005-02-14 2006-02-13 Medical device for in situ liquid drug reconstitution in medicinal vessels
AT06711163T ATE483442T1 (en) 2005-02-14 2006-02-13 MEDICAL DEVICE FOR THE RECONSTITUTION OF A LIQUID MEDICINAL PRODUCT IN SITU IN MEDICAL VESSELS
IL184960A IL184960A (en) 2005-02-14 2007-07-31 Medical device for in situ liquid drug reconstitution in medicinal vessels

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US65199905P 2005-02-14 2005-02-14
US60/651,999 2005-02-14

Publications (1)

Publication Number Publication Date
WO2006085327A1 true WO2006085327A1 (en) 2006-08-17

Family

ID=36569645

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IL2006/000181 WO2006085327A1 (en) 2005-02-14 2006-02-13 Medical device for in situ liquid drug reconstitution in medicinal vessels

Country Status (7)

Country Link
US (1) US7862537B2 (en)
EP (1) EP1848393B1 (en)
AT (1) ATE483442T1 (en)
DE (1) DE602006017334D1 (en)
ES (1) ES2354018T3 (en)
IL (1) IL184960A (en)
WO (1) WO2006085327A1 (en)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012168235A1 (en) 2011-06-06 2012-12-13 Biocorp Recherche Et Developpement Device for connection between a recipient and a container and method for assembling and using such a device
US20120323172A1 (en) * 2009-11-12 2012-12-20 Medimop Medical Projects Ltd. Inline liquid drug medical devices with linear displaceable sliding flow control member
CN108671357A (en) * 2018-06-19 2018-10-19 中国人民解放军总医院 Nasopharynx anaesthetizes watering can
US11642285B2 (en) 2017-09-29 2023-05-09 West Pharma. Services IL, Ltd. Dual vial adapter assemblages including twin vented female vial adapters
US11786443B2 (en) 2016-12-06 2023-10-17 West Pharma. Services IL, Ltd. Liquid transfer device with integral telescopic vial adapter for use with infusion liquid container and discrete injection vial

Families Citing this family (78)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL114960A0 (en) 1995-03-20 1995-12-08 Medimop Medical Projects Ltd Flow control device
US6695817B1 (en) 2000-07-11 2004-02-24 Icu Medical, Inc. Medical valve with positive flow characteristics
IL161660A0 (en) 2004-04-29 2004-09-27 Medimop Medical Projects Ltd Liquid drug delivery device
CA2586115C (en) 2004-11-05 2013-04-23 Icu Medical, Inc. Medical connector for having high flow rate characteristics
US8070739B2 (en) 2005-08-11 2011-12-06 Medimop Medical Projects Ltd. Liquid drug transfer devices for failsafe correct snap fitting onto medicinal vials
US7547300B2 (en) 2006-04-12 2009-06-16 Icu Medical, Inc. Vial adaptor for regulating pressure
US7883499B2 (en) 2007-03-09 2011-02-08 Icu Medical, Inc. Vial adaptors and vials for regulating pressure
IL182605A0 (en) 2007-04-17 2007-07-24 Medimop Medical Projects Ltd Fluid control device with manually depressed actuator
WO2009026443A2 (en) 2007-08-21 2009-02-26 Gilero, Llc Vial access and injection system
US8317743B2 (en) * 2007-09-18 2012-11-27 Medimop Medical Projects Ltd. Medicament mixing and injection apparatus
IL186290A0 (en) 2007-09-25 2008-01-20 Medimop Medical Projects Ltd Liquid drug delivery devices for use with syringe having widened distal tip
EP2214757A1 (en) * 2007-11-22 2010-08-11 Novo Nordisk Health Care AG Medical mixing device
JP5685522B2 (en) * 2008-04-01 2015-03-18 ユーコン・メディカル，リミテッド・ライアビリティ・カンパニー Duplex container fluid transfer device
WO2010022095A1 (en) 2008-08-20 2010-02-25 Icu Medical, Inc. Anti-reflux vial adaptors
US8454579B2 (en) 2009-03-25 2013-06-04 Icu Medical, Inc. Medical connector with automatic valves and volume regulator
USD641080S1 (en) 2009-03-31 2011-07-05 Medimop Medical Projects Ltd. Medical device having syringe port with locking mechanism
CA2758512A1 (en) 2009-04-14 2010-10-21 Yukon Medical, Llc Fluid transfer device
IL200547A (en) * 2009-08-23 2014-06-30 Eli Shemesh Multiple vial drug mixing system
USD630732S1 (en) 2009-09-29 2011-01-11 Medimop Medical Projects Ltd. Vial adapter with female connector
IL201323A0 (en) 2009-10-01 2010-05-31 Medimop Medical Projects Ltd Fluid transfer device for assembling a vial with pre-attached female connector
IL202069A0 (en) 2009-11-12 2010-06-16 Medimop Medical Projects Ltd Fluid transfer device with sealing arrangement
WO2011104712A1 (en) 2010-02-24 2011-09-01 Medimop Medical Projects Ltd Liquid drug transfer device with vented vial adapter
DK2512399T3 (en) 2010-02-24 2015-06-22 Medimop Medical Projects Ltd Fluid transfer device with vent arrangement
USD644731S1 (en) 2010-03-23 2011-09-06 Icu Medical, Inc. Medical connector
US8758306B2 (en) 2010-05-17 2014-06-24 Icu Medical, Inc. Medical connectors and methods of use
USD655017S1 (en) 2010-06-17 2012-02-28 Yukon Medical, Llc Shroud
CA2805918A1 (en) * 2010-08-10 2012-02-16 F. Hoffmann-La Roche Ag Drug reconstitution and delivery device
USD669980S1 (en) 2010-10-15 2012-10-30 Medimop Medical Projects Ltd. Vented vial adapter
IL209290A0 (en) 2010-11-14 2011-01-31 Medimop Medical Projects Ltd Inline liquid drug medical device having rotary flow control member
IL212420A0 (en) 2011-04-17 2011-06-30 Medimop Medical Projects Ltd Liquid drug transfer assembly
AU2012296495B2 (en) 2011-08-18 2016-03-10 Icu Medical, Inc. Pressure-regulating vial adaptors
USD681230S1 (en) 2011-09-08 2013-04-30 Yukon Medical, Llc Shroud
IL215699A0 (en) 2011-10-11 2011-12-29 Medimop Medical Projects Ltd Liquid drug reconstitution assemblage for use with iv bag and drug vial
AU2013207770B2 (en) 2012-01-13 2017-09-14 Icu Medical, Inc. Pressure-regulating vial adaptors and methods
USD674088S1 (en) 2012-02-13 2013-01-08 Medimop Medical Projects Ltd. Vial adapter
USD720451S1 (en) 2012-02-13 2014-12-30 Medimop Medical Projects Ltd. Liquid drug transfer assembly
USD737436S1 (en) 2012-02-13 2015-08-25 Medimop Medical Projects Ltd. Liquid drug reconstitution assembly
WO2013142618A1 (en) 2012-03-22 2013-09-26 Icu Medical, Inc. Pressure-regulating vial adaptors
IL219065A0 (en) 2012-04-05 2012-07-31 Medimop Medical Projects Ltd Fluid transfer device with manual operated cartridge release arrangement
USD769444S1 (en) 2012-06-28 2016-10-18 Yukon Medical, Llc Adapter device
IL221634A0 (en) 2012-08-26 2012-12-31 Medimop Medical Projects Ltd Universal drug vial adapter
IL221635A0 (en) 2012-08-26 2012-12-31 Medimop Medical Projects Ltd Drug vial mixing and transfer device for use with iv bag and drug vial
DK2872100T3 (en) 2012-09-13 2017-07-10 Medimop Medical Projects Ltd Telescopic female adapter for drug ampoule
USD734868S1 (en) 2012-11-27 2015-07-21 Medimop Medical Projects Ltd. Drug vial adapter with downwardly depending stopper
WO2014116602A1 (en) 2013-01-23 2014-07-31 Icu Medical, Inc. Pressure-regulating vial adaptors
US9089475B2 (en) 2013-01-23 2015-07-28 Icu Medical, Inc. Pressure-regulating vial adaptors
IL225734A0 (en) 2013-04-14 2013-09-30 Medimop Medical Projects Ltd Ready-to-use drug vial assemblages including drug vial and drug vial closure having fluid transfer member, and drug vial closure therefor
EP2983745B1 (en) 2013-05-10 2018-07-11 Medimop Medical Projects Ltd Medical devices including vial adapter with inline dry drug module
CA2918381C (en) 2013-07-19 2023-01-17 Icu Medical, Inc. Pressure-regulating fluid transfer systems and methods
USD767124S1 (en) 2013-08-07 2016-09-20 Medimop Medical Projects Ltd. Liquid transfer device with integral vial adapter
USD765837S1 (en) 2013-08-07 2016-09-06 Medimop Medical Projects Ltd. Liquid transfer device with integral vial adapter
GB2533714B (en) 2013-08-07 2020-04-08 Medimop Medical Projects Ltd Liquid transfer devices for use with infusion liquid containers
WO2015088862A1 (en) 2013-12-11 2015-06-18 Icu Medical, Inc. Check valve
JP6605511B2 (en) 2014-06-20 2019-11-13 アイシーユー・メディカル・インコーポレーテッド Pressure adjustment vial adapter
USD757933S1 (en) 2014-09-11 2016-05-31 Medimop Medical Projects Ltd. Dual vial adapter assemblage
USD793551S1 (en) 2014-12-03 2017-08-01 Icu Medical, Inc. Fluid manifold
USD786427S1 (en) 2014-12-03 2017-05-09 Icu Medical, Inc. Fluid manifold
JP6358724B2 (en) 2015-01-05 2018-07-18 ウエスト・ファーマ．サービシーズ・イスラエル，リミテッド Dual vial adapter assembly with easy removable pill adapter to ensure accurate use
JP6367512B1 (en) 2015-07-16 2018-08-01 ウエスト・ファーマ．サービシーズ・イスラエル，リミテッド Solution transfer device for securely snap-fitting into injection vials
USD801522S1 (en) 2015-11-09 2017-10-31 Medimop Medical Projects Ltd. Fluid transfer assembly
JP6523569B2 (en) 2015-11-25 2019-06-05 ウエスト・ファーマ．サービシーズ・イスラエル，リミテッド Dual vial adapter assembly comprising a vial adapter having a self sealing access valve
ES2915902T3 (en) 2016-01-29 2022-06-27 Icu Medical Inc Vial adapters for pressure regulation
IL245800A0 (en) 2016-05-24 2016-08-31 West Pharma Services Il Ltd Dual vial adapter assemblages including identical twin vial adapters
IL245803A0 (en) 2016-05-24 2016-08-31 West Pharma Services Il Ltd Dual vial adapter assemblages including vented drug vial adapter and vented liquid vial adapter
IL246073A0 (en) 2016-06-06 2016-08-31 West Pharma Services Il Ltd Fluid transfer devices for use with drug pump cartridge having slidable driving plunger
IL247376A0 (en) 2016-08-21 2016-12-29 Medimop Medical Projects Ltd Syringe assembly
CA3037577A1 (en) 2016-09-30 2018-04-05 Icu Medical, Inc. Pressure-regulating vial access devices and methods
USD832430S1 (en) 2016-11-15 2018-10-30 West Pharma. Services IL, Ltd. Dual vial adapter assemblage
IL251458A0 (en) 2017-03-29 2017-06-29 Medimop Medical Projects Ltd User actuated liquid drug transfer devices for use in ready-to-use (rtu) liquid drug transfer assemblages
USD903864S1 (en) 2018-06-20 2020-12-01 West Pharma. Services IL, Ltd. Medication mixing apparatus
JP1630477S (en) 2018-07-06 2019-05-07
USD923812S1 (en) 2019-01-16 2021-06-29 West Pharma. Services IL, Ltd. Medication mixing apparatus
JP1648075S (en) 2019-01-17 2019-12-16
PT3917486T (en) 2019-01-31 2023-05-08 West Pharma Services Il Ltd Liquid transfer device
DK3781113T3 (en) 2019-04-30 2024-06-03 West Pharma Services Il Ltd Dual Cavity IV Spike Fluid Transfer Device
US11340104B2 (en) * 2020-07-07 2022-05-24 Matthew Moers Syringe with a valve in a housing for measuring chemicals
USD956958S1 (en) 2020-07-13 2022-07-05 West Pharma. Services IL, Ltd. Liquid transfer device
EP4422723A1 (en) 2021-10-29 2024-09-04 Thomas C. Kuracina Method and apparatus to reduce the deadspace in syringes and small-bore devices

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4532969A (en) * 1983-09-21 1985-08-06 Kwaan Hau C Fluid withdrawal and instillation device
US5893397A (en) * 1996-01-12 1999-04-13 Bioject Inc. Medication vial/syringe liquid-transfer apparatus
EP1133970A2 (en) * 1996-06-03 2001-09-19 Applied Research Systems ARS Holding N.V. Reconstituting device for injectable medication
WO2002102295A2 (en) * 2001-05-23 2002-12-27 Elan Pharma International Limited Spike for liquid transfer device, liquid transfer device including spike, and method of transferring liquids using the same
WO2005105014A2 (en) * 2004-04-29 2005-11-10 Medimop Medical Projects Ltd Liquid drug medical device

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2807279A (en) * 1955-08-23 1957-09-24 Frank G Presnell Flow control valve
US3459403A (en) * 1967-02-13 1969-08-05 Bunkner Ind Inc Fluid metering device
LU79202A1 (en) * 1977-03-11 1978-06-28 Michelin & Cie INFLATION VALVE
US5397303A (en) * 1993-08-06 1995-03-14 River Medical, Inc. Liquid delivery device having a vial attachment or adapter incorporated therein
IL114960A0 (en) 1995-03-20 1995-12-08 Medimop Medical Projects Ltd Flow control device
US7207349B1 (en) * 2002-04-04 2007-04-24 Torque-Traction Technologies, Llc. Hydraulic flow pressure switch
AU2003252399A1 (en) 2002-08-13 2004-03-03 Satoru Hashimoto Fluid control device
US20050209555A1 (en) * 2004-03-18 2005-09-22 Lance Middleton Systems and methods for mixing fluids

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4532969A (en) * 1983-09-21 1985-08-06 Kwaan Hau C Fluid withdrawal and instillation device
US5893397A (en) * 1996-01-12 1999-04-13 Bioject Inc. Medication vial/syringe liquid-transfer apparatus
EP1133970A2 (en) * 1996-06-03 2001-09-19 Applied Research Systems ARS Holding N.V. Reconstituting device for injectable medication
WO2002102295A2 (en) * 2001-05-23 2002-12-27 Elan Pharma International Limited Spike for liquid transfer device, liquid transfer device including spike, and method of transferring liquids using the same
WO2005105014A2 (en) * 2004-04-29 2005-11-10 Medimop Medical Projects Ltd Liquid drug medical device

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120323172A1 (en) * 2009-11-12 2012-12-20 Medimop Medical Projects Ltd. Inline liquid drug medical devices with linear displaceable sliding flow control member
US20150020920A1 (en) * 2009-11-12 2015-01-22 Medimop Medical Projects Ltd. Inline liquid drug medical devices with linear displaceable sliding flow control member
US8979792B2 (en) * 2009-11-12 2015-03-17 Medimop Medical Projects Ltd. Inline liquid drug medical devices with linear displaceable sliding flow control member
US9132063B2 (en) * 2009-11-12 2015-09-15 Medimop Medical Projects Ltd. Inline liquid drug medical devices with linear displaceable sliding flow control member
WO2012168235A1 (en) 2011-06-06 2012-12-13 Biocorp Recherche Et Developpement Device for connection between a recipient and a container and method for assembling and using such a device
US11786443B2 (en) 2016-12-06 2023-10-17 West Pharma. Services IL, Ltd. Liquid transfer device with integral telescopic vial adapter for use with infusion liquid container and discrete injection vial
US11642285B2 (en) 2017-09-29 2023-05-09 West Pharma. Services IL, Ltd. Dual vial adapter assemblages including twin vented female vial adapters
CN108671357A (en) * 2018-06-19 2018-10-19 中国人民解放军总医院 Nasopharynx anaesthetizes watering can

Also Published As

Publication number Publication date
IL184960A (en) 2011-11-30
ES2354018T3 (en) 2011-03-09
US7862537B2 (en) 2011-01-04
EP1848393A1 (en) 2007-10-31
EP1848393B1 (en) 2010-10-06
IL184960A0 (en) 2007-12-03
DE602006017334D1 (en) 2010-11-18
ATE483442T1 (en) 2010-10-15
US20090054834A1 (en) 2009-02-26

Similar Documents

Publication Publication Date Title
EP1848393B1 (en) Medical device for in situ liquid drug reconstitution in medicinal vessels
US9943463B2 (en) Medical devices including vial adapter with inline dry drug module
EP2133059B1 (en) Liquid drug medical device
US7678333B2 (en) Fluid transfer assembly for pharmaceutical delivery system and method for using same
EP3366268B1 (en) Seal system for cannula
US8752598B2 (en) Liquid drug transfer assembly
US9283324B2 (en) Fluid transfer devices having cartridge port with cartridge ejection arrangement
US7736353B2 (en) Pharmaceutical delivery systems and methods for using same
CN107929858B (en) Infusion adapter for a drug delivery assembly
US5807374A (en) Syringe filling and delivery device
US5928215A (en) Syringe filling and delivery device
US20150250681A1 (en) Vial adapter for use with syringe having widened distal syringe tip
NZ570080A (en) Medical vial adapter with reduced diameter cannula and enlarged vent lumen to control the flow rate through them
NZ577635A (en) Pressure equalizing device for retaining aerosols when accessing a vial
AU2012225163A1 (en) Easy linking transfer system
WO2011004360A1 (en) Fluid transfer devices for filling a cartridge with liquid drug dosage
KR20220002472A (en) Liquid Delivery Device With Dual Lumen IV Spike
JP2023501366A (en) Adapter for Drug Mixing Injection System
WO2020205531A1 (en) Syringe assembly

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application
WWE Wipo information: entry into national phase

Ref document number: 184960

Country of ref document: IL

NENP Non-entry into the national phase

Ref country code: DE

WWE Wipo information: entry into national phase

Ref document number: 2006711163

Country of ref document: EP

WWP Wipo information: published in national office

Ref document number: 2006711163

Country of ref document: EP

WWE Wipo information: entry into national phase

Ref document number: 11816185

Country of ref document: US